北京招聘

The person will be in charge of the overall regulatory affairs for MP Biomedicals in China. Work scope includes, MPB product registration related activities for either China market or international market; Regulation affairs related to the quality assurance for diagnostic and life sciences operations. The role should act as a liaison person between China and the QA/RA department of MPB AP in Singapore for updating China regulation activities and gaining support from the headquarters.

* 负责诊断产品注册相关工作

* 代理诊断产品质量负责人执行质量管理工作以及负责我司精细化工产品的质量管理工作。

* 在总经理的领导下，负责宣传、贯彻、落实质量管理相关法律法规、方针、政策；

* 负责公司医疗器械及精细化工品的经营、仓储、养护中的质量管理、质量管理制度的制定和修改、首次经营品种和首次经营

企业的审核等有关的质量管理工作，在总经理的授权下，行使质量裁决权；

* 经常召开质量会议，组织员工学习新的医疗器械的法律法规；

* 经常检查、监督、指导公司质量管理情况；做好各类质量档案的管理工作；

• Facilitate the preparation and collation of product design / technical dossier for product registration / notification;

• Facilitate in obtaining timely approval of notifications and/or registration of all MP Bio and OEM products, licences and relevant certificates from the local regulatory bodies;

• Responsible for the application and maintenance of licences from the relevant local regulatory bodies;

• Liaise with the relevant departments and/or companies in collating Technical File for product registration / notification and CE mark registration;

• Prepare Product Standard and ensure local testing are duly completed for product registration;

• Co-ordinate the Clinical Trial and ensure clinical trial report are compliance with the CFDA and CE requirement;

• Collaborate with Singapore RA Team to compile the Technical File, ensure accurate of the translated documents;

• Be abreast with the Regulatory Guideline and Update from CFDA. Provide regulatory intelligence update on CFDA to the Regulatory Team in Singapore.

• Collate and prepare product registration status report(s) for general distribution on monthly basis to Regulatory Affairs Manager in Singapore;

• Compile and update quality assurance documents and provide internal training to staff to ensure MP Shanghai meeting CFDA requirements as an IVD trading company.

• Interacts with field sales, regional sales managers and technical support staff to understand the market situation and provide knowledge, advise and support on regulation compliance.

Qualifications:

• Demonstrate the use of all equipment, materials and techniques relevant to job performance:
  -Strong analytical skills;
  -Prepare necessary dossiers in conformance to requirements specified;
  -Perform testing / bench testing pertaining to biomedical or IVD products;
  -Ability to work with minimal supervision on projects and activities.

• Knowledge of:

  -Regulatory Affairs, Product Registration requirements and documentation relating to IVD products;
  -Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner;

• Education:

• Bachelor’s or Master’s Degree in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Physician Assistance, Pharmaceutical Science, Pharmacy;

• Experience:

• At least five years of relevant working experiences preferred in the pharmaceutical industry;

• Experience in regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities.

MP Biomedicals是全球少数能够全面提供生命科学、精细化学及临床诊断类产品的公司之一。目前生产和销售的产品超过5.5万种，在生命科学及体外诊断领域品牌认可度高，主要产品已通过欧盟CE、中国CFDA、美国FDA等卫生监管部门的认证。
经过50多年的发展，MP已经形成了布局全球的销售网络和渠道。MP 总部位于美国加利福尼亚州，在中国、新加坡、澳大利亚、法国等全球14个国家设有16家子公司。2016 年，MP被中节能万润股份有限公司全资收购，成为旗下子公司。

生命科学业务主要产品包括分子生物学产品、细胞生物学、免疫化学产品、生物化学产品以及精细化学品，主要用于基因组学、蛋白质组学、代谢组学、药物开发、食品安全检测及科学探索的其他领域
体外诊断业务主要产品包括***诊断试剂、快速诊断试剂、免疫诊断试剂及配套仪器，主要用于艾滋病、各型肝炎、癌症、心脑血管疾病、登革热等疾病的诊断及毒品滥用、内分泌水平的检测